MAUDE Adverse Event Report: NULL BCI; REMOTE OR WEARABLE PATIENT MONITORING DEVICE FOR D

Model Number 1614

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the power supply has failed.

• Brand Name: BCI
• Type of Device: REMOTE OR WEARABLE PATIENT MONITORING DEVICE FOR D
• Manufacturer (Section G): NULL
• MDR Report Key: 12685438
• MDR Text Key: 280510629
• Report Number: 3012307300-2021-10175
• Device Sequence Number: 1
• Product Code: QNY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1